FDA awards Opticyte oxygen patient monitor

The US Food and Drug Administration (FDA) has awarded medical device start-up Opticyte for its Cell O2 Patient Monitor that provides real-time, continuous monitoring of patients at risk of organ failure.

Awarded Breakthrough Device Designation, the Cell O2 Patient Monitor uses non-invasive optical spectroscopy technology to measure and detect systemic low oxygen levels inside cells.

It is hoped the device will reduce organ failure through immediate and continuous monitoring of cellular oxygen levels during hospitalisation for sepsis, trauma and myocardial infarction.

Lori Arakaki, Ph.D., Opticyte co-founder and CEO, said the designation will allow Opticyte to quickly reach sepsis, trauma, and cardiac surgery patients with organ dysfunction who are on the verge of organ failure.

The Breakthrough Device Designation programme is designed to help accelerate the regulatory approval process for devices with the potential to provide more effective treatment over existing standard of care for life-threating diseases.

Dr. Eileen Bulger, Chief of Trauma at Harborview Medical Centre, commented, “In the emergency department, we’re always racing against time.”

“Opticyte’s technology offers the potential to see continuous, real-time data indicating systemic low cellular oxygenation and allow those of us on the frontlines of care to respond with effective countermeasures to course correct potential organ dysfunction and ideally save more lives.”

According to the Centres for Disease Control and Prevention (CDC), at least 1.7 million adults in the US develop sepsis, and nearly 270,000 die as a result every year. The current standard of care for determining organ dysfunction, including for patients with sepsis, trauma or myocardial infarction, requires a blood draw, lab work, and approximately two hours of testing time.

The significant market gap in the US for these three populations across emergency and intensive care represents a $2.8bn opportunity annually, CDC states.

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